Medical Devices Development Specialist

2 days ago

Sligo, Sligo, Ireland beBeeClinicalResearchAssociate Full time €80,000 - €110,000

Our company is seeking a Senior Clinical Research Associate to manage clinical trials outsourced to CRO's and support the development of innovative medical devices in line with ISO standards, FDA regulations, EU MDR, and other applicable requirements.

Key Responsibilities:
  • Coordinate clinical investigation activities
  • Work with site staff, consultants, and teams as needed
  • Keep study product logs and inventory up to date
  • Order preclinical/clinical supplies when needed
  • Help design and write protocols for preclinical & clinical studies
  • Do literature reviews and MAUDE searches for evaluations
  • Create and update Certificates of Pharmaceutical/Precision Exponent (CEP) and Certificate of Evaluation Reports (CER)
  • Support verification & validation studies
  • Review and qualify new study sites
  • Prepare and present site initiation & device training sessions

Requirements:

  • Strong knowledge of Quality Management System (QMS), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) for medical devices and clinical studies
  • Understanding of Class III device regulations in EU, US & globally (ISO 14155 & EU MDR 2017/745)
  • 5+ years' experience in clinical studies for medical devices ideal
  • Cardiovascular experience ideal
  • Fluent in English (and local language if different)
  • Familiar with device development from pre-clinical to commercial stage
  • Knowledge of GCP in US & EU
  • High attention to detail
  • Aware of regulations for feasibility, pivotal & post-market studies, and able to adjust oversight accordingly

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